Mer­ck, Pfiz­er line up a big FDA de­ci­sion on a block­buster hope­ful, star­ing down some ma­jor league com­pe­ti­tion

Two Big Phar­ma col­lab­o­ra­tors — Mer­ck and Pfiz­er — have moved their SGLT2 di­a­betes drug hope­ful er­tugliflozin in­to the hands of reg­u­la­tors on both sides of the At­lantic.

Sam En­gel, Mer­ck

Armed with pos­i­tive piv­otal da­ta, Mer­ck and Pfiz­er are up for three PDU­FA dates in De­cem­ber now: Monother­a­py, a com­bo with best­selling di­a­betes drug Janu­via and an­oth­er com­bi­na­tion with long­time di­a­betes stan­dard met­formin. The same trio of ap­pli­ca­tions is al­so now un­der re­view in Eu­rope.

Said Sam En­gel, MD, as­so­ciate vice pres­i­dent, Mer­ck clin­i­cal re­search, di­a­betes and en­docrinol­o­gy: “If ap­proved, we be­lieve er­tugliflozin will be an im­por­tant op­tion for many pa­tients and a wel­come ad­di­tion to our al­ready strong type 2 di­a­betes port­fo­lio, with our DPP-4 in­hibitor Janu­via as the foun­da­tion.”

The mag­ic num­ber for A1C is 7.0%, which tells pa­tients that the dis­ease is be­ing well man­aged and un­der con­trol. And in the two drug arms for the phar­ma gi­ants’ piv­otal da­ta, 32.1% and 39.9% of pa­tients cleared that bar—com­pared to a less than stel­lar 17% of the place­bo arm. In­ves­ti­ga­tors al­so tracked a rel­e­vant 4.4 and 3.7 pound place­bo-ad­just­ed weight loss for their drugs. And there were sig­nif­i­cant­ly im­proved lev­els of fast­ing plas­ma glu­cose.

If they win an ap­proval, the Mer­ck/Pfiz­er team will face ma­jor league SGLT2 com­pe­ti­tion. Eli Lil­ly’s Jar­diance has been in the spot­light with a huge car­dio out­comes study in its fa­vor. And J&J’s In­vokana hit the mar­ket close to four years ago as the pi­o­neer­ing new drug in the class.

Not will­ing to play sec­ond fid­dle to Jar­diance, Mer­ck and Pfiz­er are well in­to their own big car­dio out­comes study, VER­TIS CV, with 8,000 re­cruits in the study. But they won’t get the fi­nal read­out un­til 2019.

Lil­ly, in the mean­time, won an ex­pand­ed la­bel and boast­ing rights for Jar­diance on the car­dio­vas­cu­lar out­comes at the end of 2016, even though it just bare­ly won the ex­pert pan­el vote af­ter reg­is­ter­ing a 38% drop in the risk of death. The prospect of an ex­pand­ed mar­ket boost­ed some es­ti­mates of the drug’s po­ten­tial peak sales to as high as $5 bil­lion or even $6 bil­lion a year. Lil­ly may nev­er get that far, but the num­bers haven’t es­caped the at­ten­tion of Mer­ck and Pfiz­er, which clear­ly be­lieve they can com­pete for a share.

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Purdue Pharma, the producer of the prescription painkiller OxyContin, admitted Tuesday that, yes, it did contribute to America’s opioid epidemic.

The drugmaker formally pleaded guilty to three criminal charges, the AP reported, including getting in the way of the DEA’s efforts to combat the crisis, failing to prevent the painkillers from ending up on the black market and encouraging doctors to write more painkiller prescriptions through two methods: paying them in a speakers program and directing a medical records company to send them certain patient information. Purdue’s plea deal calls for $8.3 billion in criminal fines and penalties, but the company is only liable for a fraction of that total — $225 million.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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PhRMA sues Trump gov­ern­ment over drug im­por­ta­tion rule — days be­fore it's set to be ef­fec­tive

Ever since President Donald Trump floated the idea of using state-sponsored importation to lower drug prices, PhRMA has made its opposition abundant. Not only is the proposal dangerous and futile,  but the trade group has also argued that it may even be illegal.

Now that the FDA has issued its final rule permitting states to bring certain drugs from Canada, PhRMA is taking the government to court — just a few days before the rule is slated to take effect.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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The flu virus (CDC)

Roche tacks on an­oth­er Xofluza in­di­ca­tion as flu sea­son meets pan­dem­ic

Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.

Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.